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CCO - Adverse Effects and Management Strategies
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http://www.clinicaloptions.com/inPractice/Hepatology/Hepatology/ch8_Mgmt_of_Hep_C_Infection/Pages/Page%2012.aspx
Hepatology - Management of Hepatitis C Infection
Authors: Jordan J. Feld, MD, MPH, Hemant Shah, MD, FRCPC
Adverse Effects and Management Strategies
The use of either peginterferon/ribavirin dual therapy or in combination with direct-acting antiviral agents can lead to significant adverse effects that necessitate dose reduction or discontinuation of treatment. Early recognition and intervention can help clinicians ensure patients are able to complete therapy where possible and achieve the goal of viral eradication. Although every patient will experience adverse effects to differing degrees, a systematic approach to their management can be very helpful.
* Peginterferon/Ribavirin
Table 17. Summary of Adverse Effects of Peginterferon/Ribavirin
* Protease Inhibitors: Boceprevir and Telaprevir
As both approved protease inhibitors (PIs) are used in combination with peginterferon and ribavirin, the adverse effects summarized in Table 17 apply to PI recipients.
Boceprevir
Adverse effects associated with boceprevir are summarized in Table 18. The addition of boceprevir to peginterferon/ribavirin is associated with more anemia than is seen with peginterferon and ribavirin alone.[Boceprevir PI] This can be managed with ribavirin dose reduction and, if required, erythropoietin, with no apparent loss in treatment efficacy. The additional decrease in hemoglobin seen with use of boceprevir is approximately 1 g/mL over that seen with peginterferon and ribavirin alone. Anemia resolves with discontinuation of boceprevir. The dose of boceprevir cannot be reduced under any circumstances, as this increases the risk of resistance.
Boceprevir use also causes dysgeusia in some patients. Anecdotally, taking boceprevir capsules with chocolate milk seems to help manage dysgeusia in some patients.
Table 18. Selected Adverse Effects of Boceprevir
Telaprevir
Adverse effects associated with telaprevir are summarized in Table 19. Telaprevir is associated with increased risk of cutaneous reactions (56% in randomized trials of combination therapy), which range from mild to severe.[Telaprevir PI] Mild rash refers to a localized outbreak in a limited distribution with or without pruritus but no systemic symptoms. Telaprevir may be continued in this setting. Topical steroids and oral antihistamines may be helpful, and there might be some benefit to the use of moisturizing creams or lotions. Moderate rash is more diffuse, possibly with some skin peeling but no mucous membrane or systemic symptoms. Close follow-up of these cases is required, but telaprevir may be continued, and topical steroids and antihistamines may be helpful. Systemic steroids are contraindicated. Severe rash is a generalized rash affecting > 50% of the body or any rash with vesicles, bullae, or mucous membrane involvement. In these circumstances, telaprevir should be stopped immediately. Initially, peginterferon and ribavirin can be continued; however, if the rash does not improve, all treatment should be stopped. Dermatology consultation is appropriate in this setting. Reported in less than 1% of telaprevir recipients, Stevens-Johnson syndrome (SJS) and drug rash with eosinophilia and systemic symptoms (DRESS) are medical emergencies. Symptoms include mucosal lesions, particularly with ulcerations, fever, facial edema, and/or internal organ involvement. All antiviral therapy must be stopped immediately, and expert dermatologic consultation is required.
Telaprevir also causes anemia, which can be managed with ribavirin dose reductions and/or, if necessary, erythropoietin use, without impacting treatment efficacy. Anemia may occur rapidly (within 2-4 weeks of initiation) and may be severe.[FDA Briefing; Telaprevir PI] A total of 7% (38/530) of patients treated with telaprevir in the REALIZE trial required blood transfusions. Older patients with low baseline hemoglobin and lower BMI were more likely to develop severe anemia and more advanced fibrosis was a risk factor for anemia development.[Roberts 2011] As with boceprevir, the dose of telaprevir can never be reduced. For both telaprevir and boceprevir, anemia requires closer monitoring than with peginterferon/ribavirin alone and for older patients or those with cardiac risk factors, consideration of cardiac evaluation prior to therapy may be reasonable to reduce the risk of unexpected cardiac events due to severe anemia.
Telaprevir can also cause anorectal symptoms, ranging from pruritus to pain on defecation. Local therapies such as topical steroids or, rarely, salicylate preparations may be used. Some success has been seen with the use of fiber or loperamide. Although frequent, anorectal symptoms did not lead to drug discontinuation in any of the pivotal telaprevir trials.
Table 19. Selected Adverse Effects of Telaprevir
Hector
http://www.clinicaloptions.com/inPractice/Hepatology/Hepatology/ch8_Mgmt_of_Hep_C_Infection/Pages/Page%2012.aspx
Hepatology - Management of Hepatitis C Infection
Authors: Jordan J. Feld, MD, MPH, Hemant Shah, MD, FRCPC
Adverse Effects and Management Strategies
The use of either peginterferon/ribavirin dual therapy or in combination with direct-acting antiviral agents can lead to significant adverse effects that necessitate dose reduction or discontinuation of treatment. Early recognition and intervention can help clinicians ensure patients are able to complete therapy where possible and achieve the goal of viral eradication. Although every patient will experience adverse effects to differing degrees, a systematic approach to their management can be very helpful.
* Peginterferon/Ribavirin
Table 17. Summary of Adverse Effects of Peginterferon/Ribavirin
* Protease Inhibitors: Boceprevir and Telaprevir
As both approved protease inhibitors (PIs) are used in combination with peginterferon and ribavirin, the adverse effects summarized in Table 17 apply to PI recipients.
Boceprevir
Adverse effects associated with boceprevir are summarized in Table 18. The addition of boceprevir to peginterferon/ribavirin is associated with more anemia than is seen with peginterferon and ribavirin alone.[Boceprevir PI] This can be managed with ribavirin dose reduction and, if required, erythropoietin, with no apparent loss in treatment efficacy. The additional decrease in hemoglobin seen with use of boceprevir is approximately 1 g/mL over that seen with peginterferon and ribavirin alone. Anemia resolves with discontinuation of boceprevir. The dose of boceprevir cannot be reduced under any circumstances, as this increases the risk of resistance.
Boceprevir use also causes dysgeusia in some patients. Anecdotally, taking boceprevir capsules with chocolate milk seems to help manage dysgeusia in some patients.
Table 18. Selected Adverse Effects of Boceprevir
Telaprevir
Adverse effects associated with telaprevir are summarized in Table 19. Telaprevir is associated with increased risk of cutaneous reactions (56% in randomized trials of combination therapy), which range from mild to severe.[Telaprevir PI] Mild rash refers to a localized outbreak in a limited distribution with or without pruritus but no systemic symptoms. Telaprevir may be continued in this setting. Topical steroids and oral antihistamines may be helpful, and there might be some benefit to the use of moisturizing creams or lotions. Moderate rash is more diffuse, possibly with some skin peeling but no mucous membrane or systemic symptoms. Close follow-up of these cases is required, but telaprevir may be continued, and topical steroids and antihistamines may be helpful. Systemic steroids are contraindicated. Severe rash is a generalized rash affecting > 50% of the body or any rash with vesicles, bullae, or mucous membrane involvement. In these circumstances, telaprevir should be stopped immediately. Initially, peginterferon and ribavirin can be continued; however, if the rash does not improve, all treatment should be stopped. Dermatology consultation is appropriate in this setting. Reported in less than 1% of telaprevir recipients, Stevens-Johnson syndrome (SJS) and drug rash with eosinophilia and systemic symptoms (DRESS) are medical emergencies. Symptoms include mucosal lesions, particularly with ulcerations, fever, facial edema, and/or internal organ involvement. All antiviral therapy must be stopped immediately, and expert dermatologic consultation is required.
Telaprevir also causes anemia, which can be managed with ribavirin dose reductions and/or, if necessary, erythropoietin use, without impacting treatment efficacy. Anemia may occur rapidly (within 2-4 weeks of initiation) and may be severe.[FDA Briefing; Telaprevir PI] A total of 7% (38/530) of patients treated with telaprevir in the REALIZE trial required blood transfusions. Older patients with low baseline hemoglobin and lower BMI were more likely to develop severe anemia and more advanced fibrosis was a risk factor for anemia development.[Roberts 2011] As with boceprevir, the dose of telaprevir can never be reduced. For both telaprevir and boceprevir, anemia requires closer monitoring than with peginterferon/ribavirin alone and for older patients or those with cardiac risk factors, consideration of cardiac evaluation prior to therapy may be reasonable to reduce the risk of unexpected cardiac events due to severe anemia.
Telaprevir can also cause anorectal symptoms, ranging from pruritus to pain on defecation. Local therapies such as topical steroids or, rarely, salicylate preparations may be used. Some success has been seen with the use of fiber or loperamide. Although frequent, anorectal symptoms did not lead to drug discontinuation in any of the pivotal telaprevir trials.
Table 19. Selected Adverse Effects of Telaprevir
Hector
That is interesting about the chocolate milk. I may give it a try.
Other than that, I didn't see anything new reported. All I know is that the side effects are worse than SOC. At least that is my take. ---- and never underestimate the power of anemia!
bean
Other than that, I didn't see anything new reported. All I know is that the side effects are worse than SOC. At least that is my take. ---- and never underestimate the power of anemia!
bean
Great article. Think I'll print it for my doctor so the next person who has The Rash like I did (under his care) won't have to suffer as I did.
I found that article to be an excellent article, very comprehensive, yet concise.
Glad you posted it, Hector.
Glad you posted it, Hector.
I wish I'd known about the Chocolate milk, for the dysgeusia in the beginning, but mine finally went away.
The Teleprivir crowd seem to have lots more sx, at my clinic. I also am noticing with the older females, that after their Incivek has ended, they are still experiencing the same amount of anemia, and not finding relief from Procrit.
I am only at Stage 2, so I have more time to dose myself for the required length of time, with the Boceprevir. It also makes me feel more secure, to know that I have a full 24 weeks to zap the virus, with the PI.
It is understandable, that in your case Incivek will be used, because it is the fast and furious approach. I am sure your sx will be managable, because you have a great Treatment Team, and so much education, on the subject...woot
The Teleprivir crowd seem to have lots more sx, at my clinic. I also am noticing with the older females, that after their Incivek has ended, they are still experiencing the same amount of anemia, and not finding relief from Procrit.
I am only at Stage 2, so I have more time to dose myself for the required length of time, with the Boceprevir. It also makes me feel more secure, to know that I have a full 24 weeks to zap the virus, with the PI.
It is understandable, that in your case Incivek will be used, because it is the fast and furious approach. I am sure your sx will be managable, because you have a great Treatment Team, and so much education, on the subject...woot
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